Daclatasvir Gets Denied

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FDA turns down B-MS hepatitis C drug daclatasvir

World News | November 26, 2014

By Kevin Grogan

US regulators have turned down Bristol-Myers Squibb’s New Drug Application for daclatasvir in combination with other hepatitis C drugs.

The Food and Drug Administration has issued a complete response letter on daclatasvir, requesting additional data for the NS5A complex inhibitor, in combination with other antivirals. The situation is a little complicated given that the initial daclatasvir NDA, which focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor, was withdrawn by B-MS in October.

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http://www.pharmatimes.com/article/14-11-26/FDA_turns_down_B-MS_hepatitis_C_drug_daclatasvir.aspx

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